FDA Circular No. 2020-025 || Implementing Guidelines for Administrative Order No. 2019-0019, “Reinstatement of Requirements of Licensing as Importers, Exporters, Manufacturers, Toll Manufacturers, Wholesalers, Distributors, Retailers, or Re-Packers of Those Engaged in Certain Household/Urban Hazardous Substances, and from the Requirement of Prior Registration and/or Notification of Said Products”

 OBJECTIVE:

This Circular aims to:

1. Establish the guidelines for the licensing and inspection of HUHS establishments;
2. Establish the guidelines for registration and other relevant authorizations for HUHS products;
3. Update the categorization of HUHS products;
4. Institutionalize the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) as the new hazard category for labeling of HUHS products; and
5. Ensure compliance of HUHS establishments to FDA regulatory standards, such as but not limited to Good Manufacturing Practice (GSP); or Good Distribution Practice (GDP), or Good Storage Practice (GSP); or Good Labeling Practice (GLP).

Read more:->FDA Circular No.2020-025